Patient safety

01.11.19

Ethical approval for £2.8 million trial into preventing Group B Strep in new-born babies

Announced today by Nadine Dorries, the Health Minister, Group B Strep trial has been given the go ahead by the Health Research Authority in England and Health and Care Research in Wales.

Group B Strep is the most common cause of life-threatening infections in new-born babies, causing a range of serious infections including pneumonia, meningitis and sepsis.

The outcome of the trials will be used to determine the future of pregnancy care across the United Kingdom and could help save babies lives.

80 hospitals will be involved in the trial across England, Wales and Scotland and at least 320,000 women will take part. Recruitment will start in 2020.

The trial will be funded by the National Institute for Health Research (NIHR). It will look at the efficiency of 2 different tests compared with standard care:

  • A lab-based test, the Enriched Culture Medium test at 35 to 37 weeks pregnancy
  • A beside test at the start of labour

The ECM test is currently recommended for use on high-risk groups in late pregnancy by the Royal College of Obstetricians and Gynaecologists’ clinical guidelines.

Group B Strep infections in new-born babies can usually be prevented by giving antibiotics through a vein to women during labour, which reduced the risk by up to 90%.

The UK currently does not routinely test pregnant women for Group B Strep, and instead identifies pregnant women with risk factors for their new-born developing the infection.

Research has shown:

  • There has been a 31% rise in the occurrence of Group B Strep infections in babies under 3 months old since 2000 in the UK and Ireland with 65% of the mothers of affected babies showing no risk factors
  • The bacteria are present in approximately 1 in 5 pregnant women, usually causing no harm to the carrier, but may be passed innocently from a mother to her baby around birth
  • One in 1,750 new-born babies will develop a Group B Strep infection. One in 19 of these babies will die and 1 in 14 survivors will be left with long-term disability

Health Minister Nadine Dorries said: “Every baby deserves the best start in life, so I’m thrilled this hugely important trial has been given the green light.

This is an issue I’ve been closely involved with for some time and I’m determined to do everything I can to raise awareness and help protect mothers and their new-borns from the devastating impact this infection can have.

We want the NHS to be the safest place in the world to give birth and this trial will be an important step in understanding if universal screening of Group B Strep can save the lives of more babies.”

 

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